In December 2025 Rezolute reported that its sunRIZE trial of ersodetug in congenital hyperinsulinism missed both primary and key secondary endpoints, although Week-16 CGM data showed statistically significant reductions in hypoglycemia events. All 59 participants transitioned into the open-label extension, including placebo roll-overs, and many have moved to ersodetug monotherapy while the company readies full data review ahead of a pre-Q1 FDA meeting under Breakthrough Therapy designation.

The upLIFT Phase 3 single-arm trial in hospitalized tumor HI patients is ongoing with enrollment underway for up to 16 participants and topline results expected in the second half of 2026. Historical Expanded Access Program data showed 75% of patients achieved complete discontinuation of IV dextrose/TPN, supporting the Breakthrough Designation and the single-arm registrational study design with a primary endpoint of ≥50% glucose infusion rate reduction.

As of December 31, 2025, Rezolute held $132.9 million in cash, cash equivalents and marketable securities, down from $167.9 million at June 30. R&D expenses rose to $14.3 million and G&A to $9.9 million, driven by higher clinical trial activities and one-time severance costs, contributing to a $22.8 million net loss compared with $15.7 million a year ago.